To Evaluate the Safety of 'Shinbaro Capsule'in Patients With Osteoarthritis
A 24 Weeks, Multi-centers, Single Arm Phase IV Study to Evaluate the Safety of 'Shinbaro Capsule' Compared With Historical Data of 'Celebrex Capsule' in Patients With Osteoarthritis
1 other identifier
interventional
761
1 country
18
Brief Summary
This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2012
Shorter than P25 for phase_4
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 21, 2012
CompletedFirst Posted
Study publicly available on registry
May 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedNovember 13, 2013
November 1, 2013
1.1 years
May 21, 2012
November 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of subjects with gastrointestinal adverse events
Baseline through 24 weeks
Secondary Outcomes (6)
percentage of subjects with perforation, ulcer, bleeding
baseline throgh week 24
percentage of subjects who withdrew due to GI AEs
baseline through week 24
Frequency of AEs
baseline throgh week 24
WOMAC change from baseline
24 weeks
KKS (Korean Knee Score) change from baseline
24 weeks
- +1 more secondary outcomes
Study Arms (1)
Shinbaro
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Minimum 19 years old
- Kellgren stage I \~ III by ACR criteria
- Stable osteoarthritis during 3 months
- Be able to perform WOMAC and KKS
- Written consent form voluntarily
You may not qualify if:
- Disease of orthopaedic surgical that could affect to evaluate the efficacy
- Medication of continuous corticosteroid by oral or articular cavity within 12 weeks
- Medication of constantly (more than 1 week) antipsychotic drug or narcotic analgesics within four weeks
- Medical history of hypersensitivity reaction against Herbal drug
- Genetic factors as galactose intolerance, lapplactase deficiency or glucose-galactose malabsorption, etc.
- Occurrence of OA caused by the injury
- Diagnosed with psychical disorder, and taking medication
- Diagnosed with active peptic ulcers, gastrointestinal bleeding, inflammatory bowel disease, severe liver dysfunction, severe renal dysfunction, congestive heart failure, clinically significant ischemic heart disease, peripheral arterial disease, or cerebrovascular diseases
- Diagnosed with esophagus and gastrointestinal ulceration within 1 year, or treated it
- Abnormal bleeding (abnormal of platelet or blood coagulation factor, etc.)
- Positive in fecal occult blood test
- Gastrointestinal tract surgery except appendectomy
- Serum creatinine, ALT, AST, total bilirubin over UNL x 1.5 at screening test
- Participation in another clinical trials within 4 weeks
- Not consent about using effectual contraception method during trial
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Kyungpook national university hospital
Daegu, Kyungpook, South Korea
BundangCha Hospital
Bundang, South Korea
Inje University Busan Paik Hospital
Busan, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Yeungnam University Hospital
Deagu, South Korea
Chonnam National University Hwasun Hospital
Hwasun, South Korea
Dongguk University Medical Center
Ilsan, South Korea
Inha University Hospital
Inchun, South Korea
Chonbul National University Hospital
Jeonju, South Korea
Samsung Medical Center
Seoul, 130-710, South Korea
Asan medical Center
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Inje University Seoul Paik Hospital
Seoul, South Korea
KyungHee University Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Ulsan University Hospital
Ulsan, South Korea
Related Publications (1)
Ha CW, Park YB, Kyung HS, Han CS, Bae KC, Lim HC, Park SE, Lee MC, Won YY, Lee DC, Cho SD, Kim CW, Kim JG, Kang JS, Lee JH, Choi ES, Seon JK, Lee WS, Bin SI. Gastrointestinal safety and efficacy of long-term GCSB-5 use in patients with osteoarthritis: A 24-week, multicenter study. J Ethnopharmacol. 2016 Aug 2;189:310-8. doi: 10.1016/j.jep.2016.05.031. Epub 2016 May 16.
PMID: 27196293DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
BG Lee
GC Biopharma Corp
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2012
First Posted
May 23, 2012
Study Start
May 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
November 13, 2013
Record last verified: 2013-11